BEUDAMED
    10 results · 34ms · Sources: EU EUDAMED, US FDA

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    VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL

    FDA 510(k)
    FDA Class 2 ·General Hospital

    U66 EMS

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    PSO KNEE BONE SUBSTITUTION

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRO·April 22, 2022

    PSO KNEE BONE SUBSTITUTION

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code KRO·July 18, 2019

    DEROYAL

    FDA Adverse Event
    Malfunction ·GENICON·Product code FMH·May 23, 2014

    ARMADA 14 PTA CATHETER

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code LIT·February 15, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·December 22, 2010

    UNKNOWN HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWA·February 16, 2018

    Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions: Syncope, Presyncope, Fatigue, Disorientation, Or any combination of those symptoms. Implantation of a CRT-P is indicated for: Maintaining synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic atrial fibrillation and have NYHA Class II or III heart failure. The reduction of the symptoms of moderate to severe heart failure (NYHA Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left ventricular ejection fraction d35% and a prolonged QRS duration

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017